Requests for Single Reprints: Erik A. Wallace, MD, Department of Internal Medicine, University of Oklahoma School of Community Medicine, 4502 East 41st Street, Tulsa, OK 74135; e-mail, erik-wallace@ouhsc.edu.

Current Author Addresses: Drs. Wallace and Schumann: Department of Internal Medicine, University of Oklahoma School of Community Medicine, 4502 East 41st Street, Tulsa, OK 74135.

Recent publications have emphasized the importance of physicians taking a leading role in delivering patient-centered, high-value, cost-conscious care (1–3). Scientifically valid preventive services, 19 of which were recently endorsed by the National Quality Forum (4), improve the health of the population and reduce costs by means of avoidance of expensive care for advanced disease. Low-cost screening for hypertension, dyslipidemia, diabetes, and tobacco use and treatment with lifestyle modification and medications can prevent more than 50% of heart attacks and strokes (5). However, the increasing availability of direct-to-consumer screening tests is undermining physician efforts to provide high-quality, cost-conscious screening services to patients through shared decision making.

Commercial companies may offer various screening tests, some with proven benefit, such as measurement of blood pressure and blood sugar and lipid levels. However, we are particularly concerned about the misapplication of technology (for example, ultrasonography of the carotid arteries to assess for plaques and stenosis, ultrasonography of the heel to assess for osteoporosis, and echocardiography) in the direct-to-consumer screening market as a driver of expensive and unnecessary care. Although popular with consumers and physicians alike, technology has contributed to a substantial increase in health care costs (6), and patients are increasingly demanding testing from their physicians (7).

Purveyors of these services have sprouted up all over the country, selling “packages” of screening tests outside of the traditional physician–patient relationship at “discounted” prices. Tests are offered at various locations, including churches, pharmacies, fitness centers, and shopping malls, often with a local hospital, academic medical center, or physician group as an advertising sponsor. Some companies use endorsements from celebrities, board-certified physicians, and such agencies as the Better Business Bureau to endorse the benefits of purchasing screening tests. Ultrasonography and other tests are marketed as “safe” and “harmless” to consumers because they do not use radiation or require needlesticks.

Anyone can purchase these tests—regardless of age or risk factors for disease or whether testing is truly indicated—if they are willing to pay the advertised fee. When screenings are provided in a church and sponsored by a trusted medical organization, consumers may have a false sense of trust in the quality and appropriateness of services provided. Consumers are generally unaware of the potential harms of screening (8).

In the conventional medical model, physicians or extenders should discuss age-appropriate screening tests in asymptomatic persons before ordering such testing. We acknowledge that, in many instances, suboptimal or no discussion takes place given the time constraints of routine office practice (9). Companies, through waivers and disclaimers, tell consumers to share any “abnormal” test result with their physicians; however, the specific risks and costs of potential downstream testing and treatment are generally not discussed when the screening tests are purchased and performed.

Because of a lack of counseling by these companies about the potential risks of an “abnormal” test result, the consumer is initially unaware that this may open a Pandora's box of referrals and additional testing to monitor or treat these abnormal findings. Our medical system and society bear the cost of poor coordination of care and additional testing and treatment to follow up on unnecessary “abnormal” screening test results (10). That most of these tests are not medically indicated in the first place is left undisclosed to the consumer, nor is there a discussion of potential adverse consequences or additional costs.

At a minimum, ethical considerations require that direct-to-consumer screening companies state openly for whom such screening tests are indicated on the basis of published, evidence-based guidelines; companies offering such screening tests fully inform customers of the potential risks of positive or negative screening test results before any testing is performed; and medical organizations, hospitals, and physicians refrain from sponsoring health screenings with commercial companies that offer unproven or harmful testing because it represents a clear conflict of interest. Some physicians have decried the way that medical centers sponsor such tests as a means of feeding business to high-overhead services (11).

Commercial screening companies promote the success of their products with numerous testimonials. Anecdotally, some patients actually have clinically significant disease detected before the onset of symptoms, leading to effective treatment that reduces morbidity and mortality. Others may have received an indicated screening test that insurance in conventional medical practice would have covered (such as abdominal aortic ultrasonography in men aged 65 to 75 years who previously smoked) (12).

Advocates of widespread screening may argue that if patients know that they have disease, they will be more likely to engage in behavior modification. However, evidence does not support this hypothesis. As an example, although patients who smoke and are interested in quitting have a high prevalence of carotid stenosis, those with abnormal results on carotid ultrasonography are no more likely to quit smoking than those with normal results or those who did not have an ultrasonography (13). Most commercial screening companies offer carotid ultrasonography, but the U.S. Preventive Services Task Force recommends against screening the general adult population for carotid artery stenosis because there is a moderate or high certainty that there is no net benefit or that the harms outweigh the benefits (14).

If screening asymptomatic persons in the general population with nonindicated tests neither is medically beneficial nor enhances behavior change, how can it be ethical to allow marketing of such tests to the public? We believe that promoting and selling nonbeneficial testing violates the ethical principles of beneficence and nonmaleficence (15). Although commercial screening services seem to respect patient autonomy, the failure to fully disclose the appropriate indications and consequences of testing is deceptive, because patients purchase these services with a false hope of benefit. Appropriate and truly informed consent cannot be obtained when the companies providing the test do not fully disclose the potential risks and lack of benefit before collecting payment and performing the tests.

We respect patients' autonomy to make their own medical decisions. However, choices should be informed by evidence, not such advertising claims as, “the ultrasound screenings that we offer can help save your life.” Patients can be coerced through unsubstantiated, misleading statements or omission of factual information into obtaining tests where the actual risk may outweigh the proven benefit. In direct-to-consumer advertising of pharmaceuticals, companies are required to disclose the potential risks of taking a medication. We believe that commercial screening companies should also be obligated to disclose from published guidelines the recommended indications and benefits of testing, as well as the potential risks and harms.

Judicious and appropriate use of preventive services can certainly improve the health of our population and lower overall health care costs. However, misuse of preventive services, under the guise of saving lives and saving costs, may actually lead to increased cost and harm due to unnecessary follow-up testing and treatment with associated avoidable complications. We suggest that medical entities and physicians withdraw from the unethical business of promoting unproven and potentially harmful screening tests.

Clinical Slide Sets

Terms of Use

The In the Clinic® slide sets are owned and copyrighted by the American College of Physicians (ACP). All text, graphics, trademarks, and other intellectual property incorporated into the slide sets remain the sole and exclusive property of the ACP. The slide sets may be used only by the person who downloads or purchases them and only for the purpose of presenting them during not-for-profit educational activities. Users may incorporate the entire slide set or selected individual slides into their own teaching presentations but may not alter the content of the slides in any way or remove the ACP copyright notice. Users may make print copies for use as hand-outs for the audience the user is personally addressing but may not otherwise reproduce or distribute the slides by any means or media, including but not limited to sending them as e-mail attachments, posting them on Internet or Intranet sites, publishing them in meeting proceedings, or making them available for sale or distribution in any unauthorized form, without the express written permission of the ACP. Unauthorized use of the In the Clinic slide sets will constitute copyright infringement.

In this video, Erik A. Wallace, MD, offers additional insight into his original research article, "Ethics of Commercial Screening Tests" (3:38)

This feature is available only to Registered Users

3 Comments

David L. Keller, M.D.

Providence Medical Group

December 1, 2012

In Defense of Commercial Screening Tests

I disagree with the recent Annals opinion piece (1) which condemned the ethics of commercial screening tests, mainly ultrasounds, which are sold directly to individuals, relieving them of the need to spend the time and money to get these tests ordered by a personal physician. In my area, one such company offers a package for $129 which includes ultrasound screening for carotid stenosis and plaques and also abdominal aneurysms and peripheral artery disease (2). People can actually get screened for these atherosclerotic vascular diseases (ASVDs) for less money and time than they would spend on a primary-care office visit to simply get the tests ordered. If performed at a hospital radiology department, the total fees for these tests and having them read would cost substantially more in addition. The companies which market ultrasound screening tests directly to consumers provide a way to obtain valuable and actionable information about the presence of asymptomatic ASVD in a very economical and time-efficient manner. The expenditure of this $129 could produce enormous cost savings in the long run if it identifies asymptomatic ASVD before the first ischemic event, allowing for the initiation of aggressive preventative treatment with a statin. In my experience, the vast majority of patients with asymptomatic ASVD who are identified with ultrasound screening can be treated with aspirin and aggressive LDL-lowering, and do not require the invasive procedures, such as angiograms and endarterectomies, which account for many of the downstream costs and potential “harms” of screening.The authors cite the 2007 statement by the U.S. Preventative Services Task Force (USPSTF) which advised against screening asymptomatic persons for carotid stenosis (3). However, the USPSTF advice was narrowly focused on the identification of candidates for carotid endarterectomy, and did not evaluate the more widely applicable use of ultrasound screening to identify candidates for aggressive preventative lowering of LDL cholesterol. In addition, some of the harms of screening cited by the USPSTF have been rendered obsolete by the advance of technology since 2007. For instance, they factored in the harms of downstream use of digital subtraction angiography, with its exposure to IV contrast and to ionizing radiation, and stated that the safer MRI angiography was not accurate enough to rely upon at that time. However, the accuracy and resolution of MRI technology have improved considerably since then, and many clinicians do consider MRI angiography accurate enough to base decisions on at this time.Physicians should encourage patients to identify asymptomatic ASVD by safe and economical means such as commercial ultrasound screening, even if it means relinquishing some of the power and control we have exercised in the past. We should not allow the narrowly-formulated dictates of the USPSTF to cause us to confuse the lack of proof of benefit with the proof of lack of benefit.

University of Oklahoma School of Community Medicine (Wallace and Schumann), and American College of Physicians (Weinberger)

January 2, 2013

IN RESPONSE

The letter by Dr. Keller correctly states that some of the tests offered by commercial screening companies can be obtained for less time and money than if they were ordered by their primary care physician during an office visit. In some cases, he is correct. However, through the Affordable Care Act (ACA), some recommended preventive services (such as abdominal aortic ultrasonography in men aged 65 to 75 years who previously smoked) are required to be covered by health insurance plans with no cost sharing by beneficiaries (1).

Additionally, it is important to note that our focus in the article was not primarily on the costs or the quality of the imaging, but rather on the ethical responsibility of the company or organization offering the screening tests to inform consumers about whether or not the advertised testing is recommended by clinical guidelines and/or reputable medical organizations, and if so, for which patient populations. The arguments offered by Dr. Keller do not negate the need for “truth in advertising.” It is fine for testing to be offered to consumers, as long as there are disclosures about whether and for whom each of the advertised screening tests is formally recommended by reputable sources.

We can all agree that the tests we have to offer, and the evidence and guidelines that support these tests, will change over time. We can also agree that more research needs to be done about the benefit of specific screening tests. However, as physicians, we need to embrace the responsibility to provide accurate information to patients and to engage them in shared-decision making about what, if any, testing should be ordered. We believe that encouraging patients to obtain “safe and economical” commercial screening tests that are currently not supported by scientific evidence, without providing appropriate and objective background information about accepted indications, cannot be justified.

Organizations such as the USPSTF issue guidelines which are based on the results of large clinical trials and therefore apply on average to entire populations, but may not apply to atypical individuals. We have all seen "outliers" who suffered a heart attack despite having few or no Framingham risk factors. Tests which are not justified on a population-wide basis can yield valuable information for atypical individuals. Since risk scores are not perfect at predicting who will have an adverse outcome, individuals should be allowed to decide for themselves how much risk they are willing to take, and how much of their own money they are willing to spend to assess their risk.

Consider the Affordable Care Act's mandate of free aneurysm screening for men aged 65 to 75 who have ever smoked: a man aged 65 who quit smoking 30 years ago gets a free ultrasound, but a 64 year old man who has been smoking 2 packs per day for the past 40 years does not. This makes no clinical sense, but is a perfect example of what Mark Twain meant when he said "the law is an ass [donkey]". Clinical decisions should be left to patients and their physicians, not written into law. Furthermore, these "free" ultrasounds will cost taxpayers a lot more if ordered by physicians and performed in hospital radiology departments than if patients can self-refer to commercial test companies which offer abdominal ultrasounds for $129, with carotid and peripheral artery screens included for no additional fee. The cost of hospital-based imaging is inflated in part due to excessive regulation. Commercial imaging companies can provide ultrasound at such a low cost partly because they are not yet burdened with providing mandatory counseling sessions which their customers may not even want.

Here is the crux of our disagreement. I believe that individuals in a free society should be allowed to purchase tests such as ultrasound and genetic testing, which pose no risk of direct harm. Stigmatizing commercial vendors of such tests as unethical for not providing counseling is the first step toward laws mandating counseling, which will increase the cost of the tests. To me, that outcome would be unethical.